Flexible BioPharma Manufacturing Now:Facility Design in the Dawn of Single Use

Today's, and tomorrow's biomanufacturing and personalized medicine facilities will require affordable, flexible configurations that are easy to maintain and repurpose. Join us to explore a solution available now that will replace fixed capacity configurations.

Maik W. JomitzChief Operating OfficeG-CON Manufacturing, Inc.

Maurice PhelanBioProcessServices LeaderGE HealthcareLife Sciences

George WikerVice PresidentM+W U.S., Inc.

As biopharmaceutical-processing platforms are moving from rigid stainless steel to flexible single-use technology, stable platforms create the ability to run processes more efficiently and with higher agility.

Now, focus is shifting to facility design.

Traditional facilities were product-edicated, large if not convoluted, and involved lengthy time-to-run periods. These Inflexible structures did not easily allow for scaling of cleanroom space, nor the transition of function that are the benefits of single-use technology processes.

Transitional modular structures, which are still rather inflexible, are already being replaced by autonomous cleanroom PODs. They are custom built off-site in 18 weeks and moved into the shell building erected parallel to the manufacture of the POD.

These new facility systems are reliable, scalable, and easily deployed. they can even moved, if necessary.

Bios:

Maik W. Jornitz, Chief Operating Officer, G-CON, LLC

Mr. Jornitz is a distinguished technical expert with close to 30 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. Jornitz has published multiple books, book chapters and over 100 scientific papers. He is a member of the PDA Science Advisory Board and Audit Committee, as well as an advisory board member of Artemes Technologies, Biotechnology Industry Council and multiple scientific publciations. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland

George has over twenty two years of experience in the development of cGMP manufacturing facilities and operations. George’s particular focus is in Process Architecture, often leading the conceptual design for projects, analyzing and developing process flows, operational ergonomics, compliance drivers, as well as incorporating new industry trends. George has also managed and designed pharmbio projects of various types throughout the Americas, Europe and Asia. George has been part of many project teams from concept through construction and qualification, on small projects to projects over $350MM. In addition, George also is a contributing author and lecturer, providing insight, trends, ideas and concepts to user groups and industry professionals.

Maurice Phelan, Leader BioProcess Services, GE Healthcare

Mr. Phelan leads the global BioProcess Services business at GE Healthcare. His global teams provide consulting, process development, clinical and scientific services and expertise on a wide variety of applications to support large-scale manufacturing of biopharmaceuticals.

Prior to GE, Mr. Phelan worked as a Principal at BioPharmaSolve, providing consulting and professional services to pharmaceutical, biotech, and medical device sector.

From 1993 to 2011, Mr. Phelan was Director of Global Compliance Services & Regulatory Affairs, as well as Director of BioProcess Services for Merck KGaA and Merck Millipore.

Educated at the National University of Ireland, he moved to the United States in 1987 where he began his career as a researcher at Harvard Medical School and The Children’s Hospital Boston.